A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF)
Kobayashi T, Secemsky E, Klein A, Faintuch S, Bulman J, Weinstein J, Bitton-Faiwiszewski Y, Bisharat M, Metzger D, Rosenberg R, Weinberg I, Vadlamudi V, Matthai W, Saleh A, Cristea E, Lansky A, Giri J. A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device for the Treatment of Pulmonary Embolism (ENGULF). Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102049. PMID: 39132596, PMCID: PMC11307881, DOI: 10.1016/j.jscai.2024.102049.Peer-Reviewed Original ResearchIntermediate-risk PELife-threatening bleedingPulmonary embolismRV/LV ratioAcute PEAdverse eventsThrombectomy catheterPostprocedure computed tomography angiographyTreatment of acute PEDevice-related serious adverse eventsTreatment of pulmonary embolismFirst-in-human studyPreprocedural computed tomography angiographyCatheter-directed embolectomyRight ventricle/left ventricleSecondary safety outcomesVARC-2 criteriaSerious adverse eventsDays post-procedureSingle-arm studyRisk of mortalityPrimary efficacyVARC-2Embolectomy devicesHours postprocedure